Plasma Determination of Glucagon-like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure

This study has been completed.
Sponsor:
Collaborators:
CORE
St Mark's Hospital Foundation
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180648
First received: September 12, 2005
Last updated: February 19, 2016
Last verified: May 2008

September 12, 2005
February 19, 2016
February 2005
February 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00180648 on ClinicalTrials.gov Archive Site
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Plasma Determination of Glucagon-like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure
Plasma Determination of Glucagon-like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure
The purpose of this study is to investigate the theory that the plasma level of Glucagon like peptide 2 (GLP-2) in patients with intestinal failure can predict their clinical recovery.

When major segments of small bowel have been removed surgically, or damaged by disease, the length of the residual bowel may be inadequate to maintain overall nutrition and the net result is described as "intestinal failure".

Without medical intervention, patients with intestinal failure become malnourished and dehydrated because their remaining intestine is unable to absorb enough water, vitamins and other nutrients from the ingested food. Intravenous feeding offers life saving treatment but causes complications like infections and liver problems. It also poses enormous strain on day to day life.

Glucagon like peptide 2 (GLP-2) is a naturally occurring hormone (or chemical messenger) that is able to increase the surface area of the intestinal lining (or mucosal mass) and the absorptive efficiency of the remaining intestine.

Intestinal failure patients in whom not only parts of the small bowel but also the large bowel have had to be surgically removed have been shown to have a markedly impaired rise in GLP-2 levels following meals, in contrast to patients with a preserved large bowel who have increased levels of GLP-2 and are known to have much better functional adaptation.

From this we hypothesise that the GLP-2 level is directly related to, and could predict, clinical recovery in intestinal failure as measured by Amount of parenteral nutrition required Length of hospital stay Mortality

We also aim to compare GLP-2 levels of patients with acute intestinal failure with that of patients with chronic intestinal failure as well as healthy controls

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Plasma
Non-Probability Sample
Intestinal failure patients at St Mark's hospital
Short Bowel Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and woman, aged 18 years of age or older at the time of signing the informed consent form.
  • Referral to or direct admission to St. Mark's Hospital.
  • Acute intestinal failure resulting in TPN dependency as a result of major intestinal resection performed during admission to St. Mark's or at the referring hospital.

Exclusion Criteria:

  • Inability to give consent or comply with the study.
  • Inability to take test meal (unable to be tested)
  • Severe renal impairment (interference with GLP-2 excretion)
  • Severe uncorrected anaemia (preventing additional blood-letting)
  • Uncontrolled diabetes mellitus (risk of hyperglycaemia)
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
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United Kingdom
 
NCT00180648
04/Q0405/83
Yes
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Imperial College London
Imperial College London
  • CORE
  • St Mark's Hospital Foundation
Principal Investigator: Alastair Forbes University College London Hospitals
Imperial College London
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP